Hemostatic system for body cavities

ABSTRACT

Bleeding is controlled on an inner surface of a body cavity by inserting into the cavity an expandable balloon which is covered by a hemostatic shroud, expanding the balloon, and compressing the shroud against the site of bleeding. The balloon may be disposed around a central tube to supply inflation medium. The tip of the device is soft to aid with insertion. The invention includes the corresponding devices and systems for such control of bleeding within a body cavity or passageway, as well as a method of making the devices.

This application is a continuation-in-part of U.S. patent applicationSer. No. 09/927,864 filed Aug. 10, 2001 now U.S. Pat. No. 6,706,051,which in turn is a continuation-in-part of U.S. patent application Ser.No. 09/406,166 filed Sep. 27, 1999 now U.S. Pat. No. 6,306,154, which inturn is a continuation-in-part of U.S. patent application Ser. No.09/057,414, filed on Apr. 8, 1998 now abandoned.

TECHNICAL FIELD

This invention relates generally to medical devices and methods of use,and more specifically, to materials, apparatus, and methods forfacilitating hemostasis within a body cavity or passageway.

BACKGROUND OF THE INVENTION

Nasal passageways, for example, are often susceptible to uncontrolledbleeding caused by various forms of trauma, disease or cellulardysfunction. Methods and devices for controlling, limiting or stoppingsuch bleeding would be useful in a variety of situations, ranging fromemergency room care to long term care.

Bleeding is typical after nasal related surgeries or procedures, andepistaxis related to a patient's nasal passageway can be difficult tocontrol. Hemostatic agents, such as carboxymethyl cellulose (CMC) andwoven knit or matted fabrics thereof, are known for use in the controlof bleeding, such as post-trauma and post-surgical bleeding. CMC isdefined as a polycarboxylmethyl ether of cellulose or the sodium saltthereof. It is sometimes referred to as cellulose ether,carboxymethylcellulose, or sodium caramellose. Insertion, application,and subsequent removal of these materials, however, can be difficult insmall body passageways, such as nasal cavities.

SUMMARY OF THE INVENTION

The present invention comprises methods and devices for the control ofbleeding from an inner wall of a body passageway or cavity. Briefly, theinvention comprises an inflatable, expandable balloon, usually coveredby a hemostatic shroud, which is inserted into a body cavity, such as anasal passageway. The shroud is composed of a hemostatic agent; that is,the shroud acts to facilitate or enhance blood clot formation. Theballoon component of the present invention is expanded, or inflated,within the cavity in order to press the shroud against the site ofbleeding, thereby allowing it to absorb blood and facilitate hemostasis.In specific embodiments, the shroud is composed of a woven or knittedfabric of a hemostatic fiber (such as carboxymethylcellulose) or areinforced hemostatic fiber. Optionally, this shroud may include an“extension” or “tail” fiber, which upon balloon deflation and removal,facilitates the later removal of the shroud which has been intentionallyleft in vivo.

The device construction, particularly the balloon construction, may varyaccording to the particular body cavity. Although a range of differentmaterials can be used for any of the embodiments, there are particularmaterials which work better than others, depending upon the particularapplication. For a nasal application, one embodiment includes aninflatable balloon made from a relatively inelastic material.

A particular embodiment of the invention comprises a device forinsertion of a shrouded balloon into a nasal passageway by a catheterconfigured such that the balloon encircles the catheter tube. The lumenof the catheter tube thereby serves as a passageway for breathing. Theinflated balloon compresses the shroud against the bleeding nasal wall,thereby facilitating or enhancing hemostasis. The balloon is deflatablesuch that, upon balloon deflation, the shroud may be left in place onthe cavity wall and may be removed at a later time, such as by anattached extension on the shroud.

In another embodiment, there is no central lumen. This gives thecatheter a much smaller overall diameter. In patients with small nasalcavities, the lack of the breathing passageway is more than compensatedfor by the small profile which is far less traumatic and painful duringinsertion.

The shroud used in the present invention may comprise a woven or knittedfabric combining hemostatic (e.g., carboxymethylcellulose (CMC)) fiberswith reinforcing fibers. Alternatively, the shroud may be just ahemostatic agent disposed on the balloon in a film-like covering.

DESCRIPTION OF DRAWINGS

For a better understanding of the present invention, reference may bemade to the detailed description which follows, taken in conjunctionwith the drawings, in which:

FIG. 1 is a side view of a component adapted for insertion in a nasalpassageway;

FIG. 2 is a side view of the component shown in FIG. 1 covered with ahemostatic shroud;

FIG. 3 a is a cross-sectional view of a device as shown in FIGS. 1 and2;

FIG. 3 b is a cross-sectional view of a device as shown in FIGS. 1 and2;

FIG. 4 is a schematic view of a knitted fabric structure useful in thepresent invention;

FIG. 5 illustrates another embodiment of the invention which uses apressure-indicating pilot balloon;

FIG. 6 illustrates a close-up, cross-sectional view of the inflatableballoon and shroud in accordance with the present invention;

FIG. 7 illustrates the same embodiment as illustrated in FIG. 5 with thepilot balloon deflated and turned 90°;

FIG. 8 illustrates the same embodiment as illustrated in FIG. 7 but withthe system inflated;

FIG. 9 is a partial cross-sectional view of a device according to oneembodiment of the present invention using a clamp ring;

FIG. 10 is a partial cross-sectional view of the device of FIG. 9 havinga balloon disposed between the central tube and the shroud;

FIG. 11 is a side view of one embodiment of the present invention wherethe balloon is rolled around a central tube;

FIG. 12 a is a cross-sectional view of the balloon rolled around thecentral tube;

FIG. 12 b is a cross-sectional view of the balloon unrolled and deflatedaround the central tube;

FIG. 12 c is a cross-sectional view of the balloon inflated around thecentral tube;

FIG. 13 is a cross-sectional view of the balloon rolled around thecentral tube, with a shroud disposed therearound in accordance with thepresent invention;

FIG. 14 is the cross-sectional view of FIG. 13 but with the systeminflated;

FIG. 15 is a side-view of the device shown in FIG. 11 but without thecentral tube;

FIGS. 16 a–16 e show the steps for forming a device in accordance withthe present invention using a tube tool;

FIGS. 17 a and 17 b show a deflation hole in a central tube inaccordance with one embodiment of the present invention;

FIG. 18 shows a side, partial cross-sectional view of a central tubewithout a deflation hole during deflation;

FIG. 19 is a cross-sectional view of the device with aninflation/deflation hole; and

FIG. 20 shows a device in accordance with the present invention wherethe inflation tube is not coaxial with a breathing lumen, and theinflation tube has an inflation/deflation hole.

DETAILED DESCRIPTION OF THE INVENTION

The present invention comprises systems, devices, and methods for thecontrol of bleeding in body cavities, such as nasal passageways.Generally, the terms “cavity” and “passageway” may include any bodilycavity, recess, passageway, etc., other than a blood vessel or othercomponent of the vasculature system, and it encompasses those which arehealthy and normal as well as those which are abnormal and/orpathological (meaning, diseased or unhealthy).

The term “hemostatic” agent (or material) refers to any agent ormaterial that is capable of arresting, stemming, or preventing bleedingby means other than inducing tissue growth alone. In other words,something other than tissue growth is at least partially responsible forretarding or preventing bleeding. Preferably, the agent or material willbe one that enhances blot clot formation. It will, of course, beappreciated that the agent or material may have the beneficial propertyof inducing tissue growth in addition to retarding or preventingbleeding. Examples of preferred hemostatic agents which enhance bloodcoagulation include carboxymethylcellulose (CMC), oxidized cellulose,calcium alginate, gelatine, or collagen. CMC can be purchased fromAcordis Special Fibres, PO Box 111, 101 Lockhurst Land, Coventry,England, CV6 5RS. Oxidized cellulose such as Tabotamp™, which is sold byJohnson & Johnson, New Brunswick, N.J., U.S.A., is another example of ahemostatic agent. Combinations of different hemostatic agents ormaterials may be used within the scope of the invention.

The hemostatic agent may be a part of an expansible shroud or may makeup the shroud itself. In this later case, the hemostatic agent is eithera film or fabric comprised of the hemostatic agent. In the former case,the hemostatic agent is combined with another material, such as areinforcing fiber material. Typically, the hemostatic agent-containingshroud covers an expansible device such as a balloon. The shroud may bein the form of an expandable tube or in the form of an expandable sheet.In specific embodiments disclosed, the preferred hemostatic agent is afibrous CMC, which is hemostatic and so will cause blood to clot whileat the same time absorbing any exudate. A fabric of CMC fiber ispreferred because, aside from its hemostatic properties, it swells andforms a gel, absorbing many times its own weight in fluid when itcontacts water (or blood or exudate). Because the CMC material is sohygroscopic, it does not dry into the clotted blood, and therefore canbe removed easily without tearing the clot and causing re-bleeding.

Other hemostatic agents which may be used should have absorptive andhemostatic properties similar to those of CMC. In one embodiment, thehemostatic agent fibers are woven or knitted together with reinforcingfibers, such as continuous multifilament polyester or nylon. Such aknitted fabric is illustrated in FIG. 4, and is more fully described andclaimed in separate patent applications (U.S. Ser. Nos. 09/406,490 filedSep. 27, 1999, pending; and 09/612,038 filed Jul. 7, 2000, pending; bothof which are incorporated by reference herein). The use of reinforcingfibers provides increased strength to the shroud. This increasedstrength is important for successful removal of a blood-soaked fabric,where the CMC or gellable material has formed a gel and therefore lostmuch of its strength.

Examples of some other hemostatic materials include oxidized cellulose,which is conventionally used in knitted form as a hemostatic agentduring surgery, and calcium alginate, which is a textile fiber derivedfrom seaweed and is also commonly used as a wound dressing. Furthermore,there are other polysaccharides which are available with similarchemistry and properties to CMC. For purposes of the present invention,the essential properties of the hemostatic material are the ability toabsorb large quantities of liquid without becoming enmeshed in theclotted blood. The material must be non-toxic and biocompatible.

Preferably, the shroud is provided in the form of a woven or knitted,especially a weft knitted, textile fabric in which is incorporated thehemostatic material, and which envelops the balloon. The woven orknitted textile material may be permanently or releasably fixed to theballoon.

In some embodiments, particularly those used in nasal applications, theballoon will be made of a relatively inelastic material, such aspolyurethane or PVC. Alternatively, for other uses and embodiments, theballoon can be made from an elastomeric material, such as a thinsilicone polymer. These balloons can be made by methods known to thoseskilled in the art, such as by dip molding. As noted above, it isgenerally desired in nasal applications that the balloon have a fixedvolume and be made of an inelastic material. In such a case, the balloonis effectively a bag that can be filled or emptied with an inflationmedium. A fixed volume, inflatable, inelastic balloon does not requirethe inflating medium to first stretch the elastic material of theballoon (as would be the case where the balloon is made from anelastomeric material). All inflation medium pressure is used to fill thecavity. This is essential when the device is used with a pilot balloonto give a tactile feedback of the pressure inside the catheter balloon.With an inelastic, fixed volume balloon, the tactile feedback is trulyrepresentative of the pressure applied to the inner surface of the nasalcavity.

For particular non-nasal applications, an elastic material such assilicone rubber can be used for the balloon. Such a balloon may beinflated with a liquid medium such as water or saline solution and thevolume controlled by monitoring the volume of fluid inserted. Siliconerubber has the property of being permeable to air but not to water orsaline solution.

One specific embodiment of the present invention which is designed forinsertion within a nasal passageway is depicted in FIGS. 1–3. As shownthere, a balloon catheter 50 consists of a soft flexible central tube41, with a long non-elastomeric balloon 48 adhered to the outside wallof central tube 41 along the end sections 49 of balloon 48. The wall ofcentral tube 41 includes an inflation lumen 51 (inflation passageway)which is in communication, through a thin tube 42, with a valve and luer43 at one end and an inflation port 52 at the other end. The valve 43 isopened by the tip of a standard syringe by which the balloon 48 may beinflated or deflated at will. Tube 41 includes a central breathing lumen53 which serves as an air passage for breathing.

In a specific exemplary embodiment, central tube 41 has an approximateoutside diameter of 10 mm, and an inside diameter of 4–5 mm. The activelength is typically between 40 and 100 mm, although shorter or longerlengths may be required for special applications. One end of catheter 46may have a reduction in the outer diameter in order to provide ashoulder 40. This shoulder is used to locate and maintain the positionof an outer hemostatic shroud, (seen in FIG. 2 and discussed in moredetail below), during insertion of the device of FIG. 2 into a nasalpassageway. In another method of construction the glued neck of theballoon supplies the shoulder and in yet another construction method noshoulder is used and the fabric is retained by a ring and glue or merelyby glue alone. Catheter tube 41 typically is comprised of a siliconeelastomer or PVC. In the embodiment of the present invention for use ina nasal passageway, the balloon is typically of fixed volume with anexpanded diameter of approximately 25 mm and is expanded by inflationwith air.

FIG. 2 illustrates the balloon catheter component of FIG. 1 covered by ahemostatic shroud 44 which envelopes a portion of catheter tube 41.Hemostatic shroud 44 can be a soft knitted or woven fabric tube madefrom a hemostatic material with a high absorption ability. The shroudmaterial is discussed in more detail below. Shroud 44 is draped aroundthe balloon catheter 50 and is positioned by a sewn ring or ligature 45,which locates over shoulder 40 at the distal end 46 of the ballooncatheter. The “ring over shoulder” mounting allows shroud 44 to belocated precisely over balloon 48 when the device is inserted into thenasal cavity, but permits balloon 48 to be released from shroud 44 bysimply withdrawing the catheter. Other methods of locating the shroudmay also be used, such as a glued grommet, a welded ring, or by actuallyshaping the knitted shroud for retention on the balloon. The fabricshroud is highly elastic and deformable which allows it to stretchand/or deform as the balloon is inflated. An extension tail 47 to shroud44 may be provided as a means to remove the hemostatic elementseparately after balloon 48 has been removed.

FIG. 3 a shows a cross section, in the plane A—A, of nasal catheter 50of FIG. 1 with hemostatic shroud 44 shown disposed thereon. As shown inFIG. 3, balloon 48 is covered by hemostatic shroud 44, encirclingcentral tube 41 and the non-adhered underside thereof is incommunication with inflation port 52.

In service, balloon 48 is inflated by filling material, typicallycompressed air, from a syringe in communication with valve 43 and theinflation lumen 42 which terminates in port 52 at the inner surface ofballoon 48 between the ends of the balloon which are adhered at tubesurface areas 49.

FIG. 4 illustrates a schematic view of a preferred fabric for thehemostatic shroud. Specifically, spun CMC yarn 60 is knitted in parallelwith a polyester reinforcing yarn 61, as more specifically described inthe aforementioned U.S. patent applications incorporated by reference.In this preferred embodiment, the knitted fabric tube is manufacturedfirst by knitting a tube from Lyocell yarn in combination with thereinforcing filament. Lyocell is the generic name for solvent spuncellulose fiber. A brand thereof, “Tencel,” (a registered trademark), isavailable from Accordis Fibres, Coventry UK. Lyocell is produced fromthe natural cellulose in wood pulp by dissolving the wood pulp in asolvent and then extruding the product through a die called a spinneret.The solvent is then evaporated therefrom, thereby leaving a fiber whichis composed of pure cellulose. After knitting, the fabric tube issubjected to a sodium reactant, according to known techniques, whichserves to convert the pure cellulose at least partially, into sodiumcarboxymethylcellulose. The chemical conversion process is similar tothat used to make carboxymethylcellulose sodium USP, except that the rawcellulose is in fiber form rather than the more normal powder form.Other cellulosic raw materials can also be used such as cotton orviscose rayon.

One use of the hemostatic nasal device of FIGS. 1–3 involves insertinginto a nasal cavity the shroud-covered balloon catheter 50 illustratedin FIG. 2. Balloon 48 is then inflated. Because the shroud isdeformable, it is able to expand and not limit the balloon in itsability to inflate and fill the cavity. The hemostatic fabric is pressedagainst the vessel wall and into contact with the blood. On contact withblood, the hemostatic shroud, typically CMC (or other similar material)is pressed against the cavity wall and swells to form a gel. It absorbsblood and exudate while its hemostatic properties facilitate and enhanceblood clot formation. The lumen of the large (catheter) tube providesfor normal breathing, while the inflated balloon provides an anchor forthe device. After hemostasis is achieved, the balloon 48 is deflated,and then the catheter is removed. The soft gel nature of the wet fabricshroud ensures that the device does not adhere to the clot. In oneembodiment the balloon and tube only are removed and the gelled fabricis left in situ.

Where the gelled fabric alone has been left in situ, the fabric may beremoved at any later time by means of the withdrawal string or “tail”47. Since the hygroscopic nature of the hemostatic fabric prevents thematerial from sticking to the clotted blood, removal is simple and withminimal chance of restarting the bleeding process.

In an alternative embodiment, the outer surface of the balloon itself iscoated with an agent that facilitates blood coagulation. In such anembodiment, the shroud does not comprise a fabric of any kind, but isthe hemostatic agent itself, provided in the form of a flexible filmthat coats the outer surface of the balloon. Examples of coatingmaterial include gelatin and collagen, but the invention is not limitedto these. Such an embodiment is shown in FIG. 3 b, which is identical toFIG. 3 a except that the shroud 70 is comprised only of a film ofhemostatic agent (no fabric). In slight distinction, FIG. 3 a showsshroud 44 which is comprised, as described above, of a soft knitted orwoven fabric made from a hemostatic material with a high absorptionability.

Pilot Balloon Tactile Pressure Indicator

In another embodiment, the device of this invention may include atactile pressure-indicating pilot balloon in fluid communication withthe balloon by which pressure is exerted on the hemostatic shroud. Insuch an embodiment, both the shroud compressing balloon and the pilotballoon are expandable. Preferably, both balloons are inflatable butmade of a non-stretchable material. In this embodiment, the “balloons”are really more like bags or plastic sacks which receive an inflationmedium such as air. Once the balloon is fully inflated, its volume nolonger changes because the material of which it is made does notstretch. In use the balloon will typically not be inflated to itsmaximum volume because the cavity into which the balloon is inflatedwill preferably be smaller than the theoretical maximum volume of theballoon. This is because the maximum volume and dimensions of theballoon are typically chosen to be larger than the cavity in order thatthe balloon always has the capacity to fill the cavity. In this way, thehemostatic shroud, which surrounds the balloon, is pressed against thecomplete inner surface of the cavity.

Such a pilot balloon may be disposed at the end of the inflation tubeopposite the inflatable balloon of a nasal device as shown in FIG. 5. Inthis embodiment, pilot balloon 190 is connected to first inflatableballoon 191 via inflation tube 195. Thus, the external tactile pressuresensing pilot balloon 190 does not enter the passageway but allows theuser to feel the pressure (usually by grasping the pilot between thumband finger) within the system as the first inflatable balloon 191 isinflated. In this embodiment, the pilot balloon 190 inflates along withinflatable balloon 190 during placement of hemostatic shroud 196 becausethe two balloons are in fluid communication with each other. Thus,during placement, the doctor is able to touch the pilot balloon and feelthe pressure increase as the system inflates. As discussed above, thismay be particularly important in nasal passageway applications, forexample, because too little inflation pressure may result in a lack ofblood flow stopage, and too great an inflation pressure may damage thepassageway. Thus, through a careful tactile determination of systempressure during inflation and placement of the hemostatic fabric, properand effective use of the device is insured.

In order for the tactile pressure sensing pilot balloon to give a moreaccurate indication of the pressure inside the nasal cavity, it ispreferred that the first inflatable balloon (catheter balloon) benon-stretchable. In accordance with this aspect of the invention, theballoon is made of a relatively inelastic material (such as polyurethaneor PVC) in order to have the ability of completely filling a cavitywithout any energy being used to stretch the wall of the balloon. Insuch a case, the balloon is effectively a bag that can be filled oremptied with an inflation medium. The inflatable, non-stretchableballoon does not require the inflating medium to first stretch theelastic material of the balloon (as would be the case where the balloonis made from an elastomeric material). This is preferred when the deviceis used with a pilot balloon to give a tactile feedback of the pressureinside the catheter balloon. With a non-stretchable balloon, the tactilefeedback is more representative of the pressure applied to the innersurface of the nasal cavity.

FIG. 5 also illustrates hemostatic shroud 196 disposed on firstinflatable balloon 191. As discussed above, various means forintroducing air or other suitable pressurizing fluid into the system canbe used. FIG. 5 shows a Luer slip valve 197 attached to one end of apilot balloon 190 the opposite end of which is connected via inflationtube 195. Such slip valves are known to those skilled in the art toprovide the introduction of an inflating medium, typically air, into thesystem. Also shown in FIG. 5 is fabric clamp ring 198 used to hold thehemostatic shroud 196 to the inflation tube and/or base of inflatableballoon 191. In this embodiment, which includes no central tube,inflation tube 195 ends where inflatable balloon 191 and inflation tube195 connect at clamp ring 198. In the alternative embodiment shown inFIG. 6, an inflation tube 200 actually extends into inflatable balloon191.

FIG. 6 illustrates a close-up, partially cross sectional view ofinflation balloon 191 within hemostatic shroud 196. Within inflationballoon 191 is internal inflation tube 200. Internal inflation tube 200as shown in FIG. 6 is either an integral extension of an inflation tube195 as seen in FIG. 5, or is a separate piece of tubing in fluidcommunication with an inflation tube 195 as seen in FIG. 5. Internalinflation tube 200 is shown as open at its end 205 in FIG. 6.

In FIG. 6, the hemostatic shroud 196 is shown folded back over itselfalong the length of the inflation balloon 191. In assembling the shroud196 over the balloon 191, half the fabric length is first placed overthe balloon and the excess fabric is given a complete turn (or 360°twist) before inverting the twisted excess fabric over the balloon togive the second layer of fabric. This has the effect of closing thefabric over the distal end of the balloon as shown in FIG. 6.

FIG. 7 illustrates the embodiment shown in FIG. 5 with pilot balloon 190turned 90° from the view shown in FIG. 5. FIG. 6 is presented toillustrate the deflated pilot balloon which accompanies deflatedinflatable balloon 191. After an inflation medium (preferably air ) isintroduced into the system, the resultant configuration of pilot balloon190 is shown in FIG. 8. This inflated pilot balloon 190, as shown inFIG. 8, when touched or gripped by the doctor using the device,qualitatively indicates the pressure in the system.

In one embodiment, the pilot balloon as illustrated in FIGS. 5–8, has awall thickness of about 0.09 mm (0.0035 inches) and is comprised ofpolyvinyl chloride (PVC). Typically, the pilot balloon is approximately0.5 to 2 inches in length.

In its nasal embodiments, the method comprises the steps of insertinginto a nasal cavity a first inflatable balloon surrounded at least inpart by a hemostatic shroud comprising a gel-forming absorbentcomposition. The inflatable balloon is then expanded which compressesthe shroud against the inner surface of the cavity where bleeding is tobe controlled. Where the device includes a pilot balloon, the pressureinside the inflatable balloon is monitored, during expansion of theinflatable balloon and shroud, by touching the pressure-indicating pilotballoon which is in fluid communication with the first inflatableballoon.

Nasal Applications

Soft Tip

When it is desired to use the present invention in a narrow body cavity,such as in a nasal application, several embodiments are particularlyadvantageous. One such embodiment includes a soft tip to allow easierinsertion into the nasal cavity as compared to a device not having asoft tip. The soft tip allows for less damage and irritation to the wallof the nasal cavity during insertion, particularly where the cavity doesnot exhibit smooth or straight walls. For this purpose, a soft tip canbe formed on the distal end of a shaft which is configured to beinserted into a particular body cavity.

In one such soft-tip embodiment, shown in FIG. 9, central tube 230 iscovered along its length by a suitable fabric 232, such as a CMC fabric,or a knitted CMC-reinforcing filament fabric as described above. Fabricclamp ring 234, composed for example of medical grade PVC, is disposedlongitudinally on the distal end 235 of central tube 230 and pinchesfabric 232 to tube 230. Clamp ring 234 is made from a length of verysoft flexible tubing. It is not positioned completely onto tube 230,however, but extends longitudinally beyond distal end 235 of tube 230.

During manufacture of this embodiment, a cylindrical piece of fabric 232is slipped over central tube 230 and clamp ring 234 is slid over fabric232 and part way on to central tube 230. Then, fabric 232 is foldedback, and inverted, around tube 230 to create a double layer of fabricalong tube 230. After fabric 232 is folded, a folded section 236 iscreated. This folded region 236, draped over the very soft flexibleclamp ring 234, forms a soft tip which reduces trauma as the device isinserted into a body passageway.

In one embodiment, glue can be used to set clamp ring 234 into place.The glue would be placed between fabric 232 and tube 230 where the clampring overlaps tube 230. A preferred glue is a cyanoacrylate based glue,a more preferred glue being Loctite 4011. Loctite is a registeredtrademark of Loctite Corporation.

FIG. 10 shows the embodiment of FIG. 9 but with a balloon 240 disposedbetween shroud 232 and central tube 230. Balloon 240 is attached towardthe distal end of central tube 230 by any of a number of means,including the use of glue or heat sealing the balloon directly tocentral tube 230 at its distal end 241. Means for inflating balloon 240are not shown in FIG. 10, but are addressed in other parts of thisspecification.

A second way to achieve the soft tip of the invention is used on theversion which does not include a central airway or breathing tube. Thisinvolves rolling the balloon around the central tube or rolling theballoon around itself underneath the fabric (See FIG. 15). In the formerembodiment, a thin-walled balloon is disposed on a central tube and,when deflated, is flattened and rolled around the tube around the samelongitudinal axis defined by the central tube, similar to how a roll ofpaper towels are disposed around a cardboard tube. FIG. 11 shows such anembodiment where balloon 240 is rolled around central tube 230. Balloon240 is sized so as to extend beyond the distal end of central tube 230.The region of extension 245 provides a soft tip for the device whichachieves the above described advantages during placement. Preferably,the balloon is made from a film welding technique to achieve a very thinwalled balloon. Typical materials for the balloon include PVC andpolyurethane. Any suitable polymer would work, so long as it is easilywelded and maintains adequate strength to allow expansion of aninflation medium without breaking.

Film welding techniques (including radio frequency welding) are wellknown to those skilled in the art and are used in a variety of largerproducts such as blood bags, intravenous (IV) drug bags, pouches forcard or badge protection, etc. Generally, the thinner the material, thebetter, so long as adequate strength is insured. The preferred thicknessfor the balloon thin film material is between 0.03 mm and 0.15 mm. Thecombination of this very thin walled balloon along with a thin inflationtube and thin fabric allows for a very small diameter device. Thesmaller the diameter, the easier the device can be inserted into a nasalpassageway.

FIGS. 12 a–12 c show three cross sections of balloon 240 and centraltube 230. FIG. 12 a shows the balloon rolled around central tube 230.FIG. 12 b shows the balloon 240 unrolled but not fully inflated aroundcentral tube 230, and FIG. 12 c shows the balloon 240 inflated aroundcentral tube 230. FIG. 13 shows the cross section of FIG. 12 a withshroud 232 shown disposed around the balloon 240. When central tube 230receives inflation medium (typically air), the medium passes through apassageway, typically a hole (not shown) in the wall of tube 230 andinto the interior of balloon 240. Balloon 240 then expands and unrollswithin shroud 232 and expands to cause shroud 232 to contact the innersurface of the body passageway or cavity where bleeding is to becontrolled. FIG. 14 shows balloon 240 expanded within shroud 232. FIGS.13 and 14 show the shroud 232 as a two layer shroud, consistent with theembodiment shown in FIG. 10. The shroud could, however, be singlelayered or have more than two layers.

The balloon rolling does not have to be rolled around a central tube. Asdescribed above, no central tube is present in some embodiments. In sucha case, the fabric would be disposed around a rolled balloon where theballoon is simply rolled up on itself. An example of this laterembodiment is shown in FIG. 15. A tubular connection for introducinginflation media would obviously be included. A forceps or otherinstrument may be required to deploy such an embodiment.

Twisted Fabric Construction

In another embodiment, the shroud is attached to the inflation lumen atonly the proximal end of the device, as shown in FIGS. 6 and 16 e. Here,shroud 232 is doubled-up, back over itself along the length of centraltube 230. In this embodiment, however, and unlike the embodiment shownin FIG. 9, the assembly of shroud 232 over balloon 240 involves thetwisting of the fabric at its distal end. Here, half the fabric lengthis first placed over the balloon and the excess fabric is turned,preferably in a complete turn (or 360° twist) at its distal end beforeinverting the twisted excess shroud back over the balloon and firstlayer of shroud to provide the second layer of shroud. This has theeffect of closing the shroud over the distal end of the balloon as shownin FIG. 6. In such an embodiment, balloon 240 is only secured to centraltube 230 at its proximal end. This allows for the use of only oneattachment means for the entire device, such as glue or a clamp ring257.

The present invention also includes a method for manufacture of a deviceas represented in FIG. 6. This method, as shown in FIGS. 16 a–16 e,involves the use of an assembly tool 260 as shown in FIG. 16 b. Thistool is a relatively thin-walled cylinder and is made from a relativelyrigid, or stiff, preferably transparent material.

The method first requires the placement of shroud 232 over the balloon240 and central tube 230, as shown in FIG. 16 a. In the next step,assembly tool 260 is pushed into shroud 232, which shroud issimultaneously stretched around the outside surface of assembly tool260, as shown schematically in FIG. 16 b. FIG. 16 c illustrates thethird step, which requires rotating assembly tool 260, and shroud 232along with it. The preferred rotation is 360°, although more rotationwould achieve the same purpose. The next step is shown in FIG. 16 d,which illustrates the progression of assembly tool 260 toward theproximal end of the device, which causes shroud 232 to double over onitself, forming a double layer of fabric along the outside surface ofballoon 240. FIG. 16 e shows the result of this method, after a clampring 257 is placed around shroud 232 at the proximal end of the device,thereby securing the fabric in place. Any excess fabric that wouldextend beyond the clamp ring 257 could then be trimmed from the device.

Glue could also be used with this embodiment. During the step of placingclamp ring 257, a small amount of glue could be injected under the clampring at two spots, one each at 180° from the other around thecircumference of the inflation tube where clamp ring 257 will besecured. Because the fabric is meshed, in the preferred embodiment, theglue will contact the fabric, the inflation tube, and the inside of theclamp ring, binding all three components together.

This method can also be used to place fabric around a device which hasno central inflation lumen, but which has only an inflation balloonattached to the distal end of the inflation tube. Such an embodiment isshown in FIG. 5. In such a case, only the balloon and fabric extendbeyond the distal end of the inflation tube.

In some embodiments of the invention, particularly those not including abreathing lumen, there is a risk that upon deflation, the balloon and/orsurrounding fabric will be sucked into the passageway by which inflationmedium passes from the central tube into the balloon. This isillustrated in FIG. 18, wherein balloon 240 is shown sucked into ablocking position at distal end 275 of central tube 230. This may resultin preventing complete deflation of balloon 240.

To prevent this potential problem, a hole may be formed in the centraltube wall as shown in FIGS. 17 a, 17 b, and 19. As shown in FIGS. 17 aand 17 b, hole 261 is formed so that inflation medium can enter and bewithdrawn from a balloon surrounding the central tube 230. The inflationmedium can pass both at the distal end of the central tube 230 andlaterally through hole 261. This prevents a deflation limitation orstopage which could result at the distal end of central tube 230, asshown in FIG. 18. FIG. 19 shows a cross-sectional view of central tube230 having hole 261 with balloon 240 and shroud 232 disposedtherearound.

FIG. 20 illustrates an embodiment having a breathing tube 301 whereinflation lumen 300 is disposed within the wall of breathing tube 301.In this embodiment, balloon 302 is shown disposed around breathing tube301, and inflation lumen 300 is disposed radially offset from thecentral axis of breathing tube 301. Here, inflation lumen 300 extendsalong the entire length of breathing tube 301, and is blocked at itsdistal end by glue 303. Alternatively, inflation lumen 300 could beformed so as not to continue all the way to the end of the breathingtube 301 (as shown in FIG. 1). The important aspect of inflation lumen300 is that it not be open at the breathing tube's distal end.

To allow delivery of inflation medium to balloon 302, a hole 304 isprovided along inflation lumen 300. The hole could be formed from anumber of different techniques. A preferred method of making the hole inthis embodiment includes the use of a punch. The punch is a metal tube,with one end sharpened like a circular knife, which is inserted into theside of breathing tube 301 only far enough to create the hole 304. Theuse of a punch, instead of a conventionally drilled hole, helps insurethat a conventional drill does not continue into the breathingpassageway and open a hole there during manufacture of the device.

An additional advantage to using the punch, instead of a conventionaldrill, is that, unlike a conventional drill, the punch cuts a clean holeand does not create loose material or shavings which could be difficultto remove from the device and could cause a contamination hazard duringlater use of the device. By using the punch, the punched material isremoved within the shaft of the punch and discarded.

The foregoing comprises a description of certain exemplary embodimentsof the present invention. The invention is not limited to theseembodiments, however, and the subjoined claims are intended to beconstrued to encompass all embodiments of this invention, andequivalents and variants thereof, which may be made by those skilled inthe art without departing from the true spirit and scope of theessential concepts disclosed and claimed herein.

1. A device for controlling bleeding on an inner wall of a body cavityor passageway comprising: an insertable shaft having a distal end, saidshaft comprised of a hemostatic shroud disposed around an innercomponent, said inner component having a distal end, said shaft having asoft tip on said distal end of said shaft, and said shroud disposedaround said shaft and extending beyond both the distal end of said innercomponent and the distal end of said shaft.
 2. The device of claim 1,wherein said inner component comprises a central tube and said soft tipcomprises a length of said hemostatic shroud, supported by a length ofsoft flexible tubing projecting beyond the distal end of said centraltube.
 3. The device of claim 1, wherein said inner component comprises aballoon and said soft tip comprises the distal end of said ballooncovered by said hemostatic shroud.
 4. The device of claim 3, whereinsaid inner component comprises a central tube and said balloon is rolledaround said central tube, the distal end of said balloon extendingbeyond the distal end of said central tube.
 5. The device of claim 4,wherein said inner component is a balloon and does not include a centraltube.
 6. The device of claim 3 wherein said balloon is inelastic.
 7. Thedevice of claim 2 wherein a first portion of said hemostatic shroudsurrounds said inner component and a second portion thereof extendsbeyond the distal end of said inner component and is folded back overthe first portion.
 8. The device of claim 1 wherein said hemostaticshroud is comprised of a fabric comprised of a gel-forming absorbentcomposition.
 9. The device of claim 1 wherein said hemostatic shroud iscomprised of a gel-forming absorbent composition film.
 10. The device ofclaim 1 wherein said hemostatic shroud is comprised of hemostatic agentfibers knitted or woven together with reinforcing fibers.
 11. The deviceof claim 10 wherein said reinforcing fibers are one of polyester andnylon.
 12. The device of claim 1 wherein said hemostatic shroud iscomprised of hemostatic agent yarn knitted or woven together withreinforcing yarn.
 13. The device of claim 12 wherein said reinforcingyarn is comprised of nylon or polyester.
 14. A device for controllingbleeding on an inner wall of a body cavity or passageway comprising: aninsertable shaft having a distal end, said shaft comprised of ahemostatic shroud disposed around an inner component, said innercomponent having a distal end and a balloon, said shaft having a softtip on said distal end of said shaft, and said shroud disposed aroundsaid shaft and extending beyond both the distal end of said innercomponent and the distal end of said shaft.
 15. The device of claim 14,said soft tip comprises the distal end of said balloon covered by saidhemostatic shroud.
 16. The device of claim 14 wherein said balloon isinelastic.